Status:
COMPLETED
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Lead Sponsor:
Celgene
Conditions:
Chronic Lymphocytic Leukemia
Leukemia, B-Cell, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjec...
Eligibility Criteria
Inclusion
- Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
- ECOG \< or = 2
- Willing to agree to follow the pregnancy precautions.
Exclusion
- Pregnant or nursing women
- Systemic treatment for B-cell CLL within 28 days of study start
- Central nervous system involvement
- History of renal failure requiring dialysis
- Prior treatment with lenalidomide
- Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
- ANC \< 1000 / ul
- Platelet count \< 50,000 / ul
- Calculated creatinine clearance \< 60 mL/min (Cockroft-Gault method)
- AST or ALT \> 3.0 x upper limit of normal
- Serum total bilirubin \> 2.0 mg/dl
- Neuropathy \> or = Grade 2
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Richter's transformation (active)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00419250
Start Date
December 1 2006
End Date
June 1 2010
Last Update
November 8 2019
Active Locations (35)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
3
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
4
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207